A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma

ISRCTN	ISRCTN88796215
DOI	https://doi.org/10.1186/ISRCTN88796215
Secondary identifying numbers	NICCO CRCI

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	A randomised trial of adjuvant 5-fluorouracil, leucovorin and radiotherapy in colorectal adenocarcinoma
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Colon, Rectal cancer
Intervention	COLON CANCER: Following surgery patients are randomised to one of two groups: 1. Group A: No adjuvant therapy 2. Group B: Adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14 days for eight courses. RECTAL CANCER: Following surgery patients are randomised to one of two groups: 1. Group A: No adjuvant therapy 2. Group B: Radiotherapy 4400 cGy in 22 daily fractions plus adjuvant chemotherapy with 5-fluorouracil and folinic acid repeated every 14 days for eight courses. Radiotherapy to be given five days per week prior to or concurrent with chemotherapy.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	5-fluorouracil and folinic acid (leucovorin)
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/08/2002
Completion date	01/08/2003

Participant type(s)	Patient
Age group	Other
Sex	Both
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Aged 18 to 80 years 2. World Health Organisation (WHO) performance status zero to two 3. Histological proof of colorectal adenocarcinoma 4. The entire colorectum must be visualised pre- or postoperatively to exclude synchronous carcinoma 5. Potentially curative surgery 6. Adjuvant treatment to be initiated within six weeks of surgery 7. Adequate bone marrow, renal and hepatic function
Key exclusion criteria	No previous malignancy except carcinoma in situ of cervix or basal cell carcinoma of skin
Date of first enrolment	01/08/2002
Date of final enrolment	01/08/2003

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Wyeth-Lederle Ltd (UK)
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SL6 0PH
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Wyeth-Lederle Ltd (UK)

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Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan